Herbo-mineral formulation for prevention, treatment and management of diabetes and method of preparation thereof

ABSTRACT

Herbo-mineral formulation for prevention, treatment and management of Diabetes and method of preparing the same are disclosed herein. The disclosed herbo-mineral formulation includes herb and mineral elements which facilitate in treating Diabetes and Diabetes associated complications. Further the disclosed formulation has been observed to exhibit hypoglycemic, hypolipidemic, and pancreatic cell regenerative properties.

CROSS REFERENCE TO RELATED APPLICATION

This application is based on and derives the benefit of U.S. ProvisionalApplication 62/489,142 filed on Apr. 24, 2017, the contents of which areincorporated herein by reference.

TECHNICAL FIELD

The embodiments disclosed in this specification relates to herbo-mineralformulation effective in the treatment, management and prevention ofDiabetes, in particular Diabetes mellitus and related complications. Italso relates to the process of preparation of such formulation.

BACKGROUND

Diabetes is a condition, an epidemic, associated with increased bloodsugar level (hyperglycemia). The condition is a result of impairedglucose uptake by cells. Glucose uptake by cells from the blood streamis facilitated by Insulin. Inadequate insulin production by pancreas orinability of the body to use the produced insulin causes Diabetes.

While, family history is considered as one of the risk factors indeveloping Diabetes, lifestyle and environmental factors also play arole in increasing the risk. Lifestyle factors including lack ofphysical activity, obesity, poor diet, cigarette smoking, etc. increasethe risk of developing Diabetes.

Diabetes is considered as a condition that lasts a lifetime and that canonly be controlled but may never be cured. The disease when uncontrolledcould lead to various life threatening complications such as glaucoma,neuropathy, atherosclerosis, kidney failure, hypertension, depression,anxiety, gastroparesis, stroke, diabetic hyperlipidemia, etc.

Diabetes not just affects the quality of life of an individual on a dayto day basis but also increases the risks of severity and complicationsin case of any health incident. In any case, managing/handling diabeticpatient is a complicated and expensive affair considering the nature ofspecial care that may have to be implemented.

Existing treatment methods include hypoglycemic drugs, Insulininjections, and so on. However, such allopathic interventions have beenknown to have side effects such as nausea, vomiting, drowsiness,numbness, muscle pain, etc.

Alternatively, ayurvedic treatment methods have also been developed totreat Diabetes. Ancient teaching of Ayurveda disclose the use of herbssuch as Glycerrhiza glabra, Terminalia bellirica, Phyllanthus emblica,Terminalia arjuna, Santalum alba, Terminalia chebula and Curcuma Longain treatment of Diabetes. Many other formulations including herbs suchas Berberis aristata, Rubi cordifolia, Trigonella foenum graecum,Azhadirachta indica, Curcuma Longa and Tinospora Cordifolia have alsobeen developed. It has been observed that about half of the patientswith Type II diabetes mellitus can be managed with diet and exercise,and when Ayurvedic treatment is followed dose of insulin can be reducedeven in Type I insulin dependent diabetes mellitus. While Ayurvedictreatment has many benefits, the effectiveness of most Ayurvedic herbalformulations is arguable. There exists a need for an effective method oftreating/managing Diabetes.

OBJECTS OF THE DISCLOSED EMBODIMENTS

The principal object of the embodiments disclosed herein is to provide acomposition and method of treating Diabetes and Diabetes associatedcomplications.

A second object of the embodiments disclosed herein is to provide acomposition and method of managing Diabetes and Diabetes associatedcomplications.

Another object of the embodiments disclosed herein is to provide acomposition and method of preventing Diabetes and Diabetes associatedcomplications.

Another object of the embodiments disclosed herein is to provide aherbo-mineral formulation and a method for its preparation.

These and other objects of the embodiments herein will be betterappreciated and understood when considered in conjunction with thefollowing description and the accompanying drawings. It should beunderstood, however, that the following descriptions, while indicatingpreferred embodiments and numerous specific details thereof, are givenby way of illustration and not of limitation. Many changes andmodifications may be made within the scope of the embodiments hereinwithout departing from the spirit thereof, and the embodiments hereininclude all such modifications.

BRIEF DESCRIPTION OF FIGURES

The embodiments disclosed herein are illustrated in the accompanyingdrawings, throughout which like reference letters indicate correspondingparts in the various figures. The embodiments herein will be betterunderstood from the following description with reference to thedrawings, in which:

FIG. 1(a) depicts a flowchart for the preparation of Swarna MakshikaBhasma;

FIG. 1(b) depicts a flowchart for the preparation of Abhraka Bhasma;

FIG. 1(c) depicts a flowchart for the preparation of Loha Bhasma;

FIG. 1(d) depicts a flowchart for the preparation of Vanga Bhasma;

FIG. 1(e) depicts a flowchart for the preparation of Pravala Bhasma;

FIG. 1(f) depicts a flowchart for the preparation of Yashada Bhasma;

FIG. 2 depicts a flowchart for the preparation of fortified tablets;

FIG. 3 is a graph depicting the results of the Oral glucose tolerancetest in normal and diabetic rats treated with the embodiments disclosedherein.

FIG. 4 is a graph depicting the effect of administering the embodimentsdisclosed herein on protein depletion in diabetic rats;

FIG. 5 is a graph depicting the reduction in tissue glycogen depletionby treatment with the embodiments disclosed herein;

FIG. 6 depicts tissue lipids of normal and diabetic rats after treatmentwith the embodiments disclosed herein;

FIG. 7 depicts Cholesterol of normal and diabetic rats after treatmentwith the embodiments disclosed herein;

FIG. 8 depicts tissue phosphatases in rats treated with the embodimentsdisclosed herein;

FIG. 9 depicts tissue transaminase in rats treated with the embodimentsdisclosed herein;

FIG. 10(a) represents a photomicrograph of Pancreatic islet from normalrats (200×) treated with the embodiments disclosed herein;

FIG. 10(b) represents a photomicrograph of Pancreatic islet from alloxaninduced diabetic rats showing degranulation and necrotic B cells (300×)treated with the embodiments disclosed herein; and

FIG. 10(c) represents a photomicrograph of pancreatic islet fromdiabetic rats treated with the embodiments disclosed herein, accordingto the embodiments herein.

DETAILED DESCRIPTION

The embodiments herein and the various features and advantageous detailsthereof are explained more fully with reference to the non-limitingembodiments that are illustrated in the accompanying drawings anddetailed in the following description. Descriptions of well-knowncomponents and processing techniques are omitted so as to notunnecessarily obscure the embodiments herein. The examples used hereinare intended merely to facilitate an understanding of ways in which theembodiments herein may be practiced and to further enable those of skillin the art to practice the embodiments herein. Accordingly, the examplesshould not be construed as limiting the scope of the embodiments herein.

The embodiments herein achieve a herbo-mineral formulation oftherapeutic value, and a process for the preparation of the formulation.The herbo-mineral formulation disclosed herein is useful in thetreatment, prevention and management of Diabetes and related metabolicdisorders. The formulation, disclosed in the various embodiments herein,may also be used to treat hyperglycemia, hyperlipidemia, and othercomplications associated with Diabetes. It has also been observed thatthe embodiments of the disclosed formulation may be instrumental inpreventing the complications of diabetes like retinopathy, neuropathy,nephropathy and vascular diseases. The herbo-mineral formulation,further, has been observed to have hypoglycemic, hypolipidemic,cytoprotective and immunomodulatory activities. The formulation may beused as monotherapy or as an adjunct with other oral hypoglycemic drugs.

Further, disclosed herein is a method of regenerating beta cells (βcells) and increasing cell mass in pancreas. The embodiments disclosedherein have surprisingly been observed to stimulate regeneration of βcells of islets of pancreas of diabetic rats. Accordingly, theembodiments disclosed herein achieve a method for the treating/managingDiabetes.

Formulation

The disclosed embodiments herein provide herbo-mineral formulationhaving a combination of selected herbs and minerals. In an embodiment,the herbo-mineral formulation includes herb element and mineral element.In another embodiment, the herbo-mineral formulation includes herbelement, mineral element along with suitable excipient.

Herb Element

In an embodiment, the herb element includes the herbs Salacia chinensis,Gymnema sylvestre, Emblica officinalis, Eugenia jambolana, Curcumalonga, Commiphora mukul (Guggulu) and Tinospora cordifolia or theirextracts, or the active ingredients extracted from these herbs. Inanother embodiment, the herb element further includes at least one ofthe herbs selected from Withania somnifera, Terminalia chebula,Terminalia bellerica, Andrographis paniculata, Boerhavia diffusa,Azhadirachta indica, Aristolochia indica, Aegle marmelos, Cyperusrotundus, Hemedesmus indicus, Trichosanthes dioica, Santalum alba,Terminalia arjuna, Woodfordia fruiticosa, Glycerrhiza glabra, Mucunapruriens, Myrica nagi, Plumbago rosea, Inula racemosa, Zingiberofficinalis, Piper longum and Piper nigrum or their extracts, or theactive ingredients extracted from these herbs.

The herb element may be a specific part of the herb (also referred asherb component) such as roots, flowers, fruits, stem, bark, resin,rhizome, whole plant, etc. In an embodiment, the herb element mayinclude roots of Salacia chinensis, Withania somnifera, Boerhaviadiffusa, Aristolochia indica, Aegle marmelos, Cyperus rotundus,Hemedesmus indicus, Glycerrhiza glabra and Plumbago rosea; fruits ofTerminalia chebula, Terminalia bellerica, Emblica officinalis, Piperlongum and Piper nigrum; bark of Azhadirachta indica, Myrica nagi andTerminalia arjuna; plant of Andrographis paniculata and Trichosanthesdioica; leaves of Gymnema sylvestre; heartwood of Santalum alba; flowersof Woodfordia fruiticosa; seeds of Mucuna pruriens and Eugeniajambolana; rhizome of Curcuma longa and Zingiber officinalis; gum resinof Commiphora mukul, and stem of Tinospora cordifolia or their extract.However, it is also within the scope of the claims provided herein forthe herbo-mineral formulation to include other herb components such asleaf, flowers, etc. without otherwise deterring intended function of theherbo-mineral formulation.

The herb component maybe included in the formulation in any form that isgenerally known in the field. For example, the herb component may bedried, powdered, processed to form concentrates, extracts, etc. In onepreferred embodiment, the herb components are dried and powdered whichis further incorporated into the formulation.

In an embodiment, the herb element includes Salacia chinensis in therange of 4 to 8 wt %, Gymnema sylvestre in the range of 4 to 8 wt %,Emblica officinalis in the range of 2 to 6 wt %, Eugenia jambolana inthe range of 4 to 8 wt %, Curcuma longa in the range of 3 to 7 wt %,Commiphora mukul (Guggulu) in the range of 3 to 7 wt % and Tinosporacordifolia in the range of 3 to 7 wt %. Further, in another embodiment,the herb element includes atleast one of Withania somnifera, Terminaliachebula, Terminalia bellerica, Andrographis paniculata, Boerhaviadiffusa, Azhadirachta indica, Aristolochia indica, Aegle marmelos,Cyperus rotundus, Hemedesmus indicus, Trichosanthes dioica, Santalumalba, Terminalia arjuna, Woodfordia fruiticosa, Glycerrhiza glabra,Mucuna pruriens, Myrica nagi, Plumbago rosea, Inula racemosa, Zingiberofficinalis, Piper longum and Piper nigrum in an amount in the range of0 to 4 wt %.

Mineral Element

In an embodiment, the mineral element includes Bhasmas or calcinedpreparations such as Swarna Makshika bhasma, Abhraka bhasma, Lohabhasma, Vanga bhasma, Yashada Bhasma and Pravala bhasma. Alternatively,the mineral element may also be selected from a group consisting of atleast one of mica, tin, lead, zinc, coral, iron and copper pyrite. Inthe disclosed embodiments, the bhasmas along with the herb element formbioavailable herbo-mineral complexes which are useful in treating,preventing and managing Diabetes and associated complications. In anembodiment, the mineral element further includes Shilajit. However, itis also within the scope of claims provided herewith for theherbo-mineral formulation to include, as a substitute or additionally,other similar calcined preparations or minerals without otherwisedeterring from the intended function of the herbo-mineral formulation.

In an embodiment, the mineral element includes shilajit in the range of2 to 6 wt %. In another embodiment, the mineral element includes AbhrakaBhasma is in an amount of ≤2 wt %, Vanga Bhasmais in an amount of ≤1 wt%, Yashada Bhasma is in an amount of ≤1 wt %. Pravala Bhasma is in anamount of ≤2 wt %, Loha Bhasma is in an amount of ≤2 wt % and SwarnaMakshika Bhasma is in an amount of ≤2 wt %.

The disclosed formulation, in the various embodiments herein, mayfurther include a suitable excipient. The suitable excipients includesolvents, binders, lubricants, herbal carriers, oils and salts that aregenerally known in the art. In a preferred embodiment, the excipientincludes acacia gum.

Further, the amount of herb element and mineral element that may beincluded in the various embodiments of the disclosed formulation may bein the range of 0 to 10 wt %. In an embodiment, the formulation includesSalacia chinensis (4 to 8 wt %), Gymnema sylvestre (4 to 8 wt %),Emblica officinalis (2 to 6 wt %), Eugenia jambolana (4 to 8 wt %),Curcuma longa (3 to 7 wt %), Commiphora mukul (Guggulu) (3 to 7 wt %),Tinospora cordifolia (3 to 7 wt %), Shilajit (2 to 6 wt %), AbhrakaBhasma (≤2 wt %), Vanga Bhasma (≤1 wt %), Yashada Bhasma (≤1 wt %),Pravala Bhasma (≤2 wt %), Loha Bhasma (≤2 wt %) and Swarna MakshikaBhasma (≤2 wt %).

In another embodiment, the formulation further includes atleast one ofWithania somnifera, Terminalia chebula, Terminalia bellerica,Andrographis paniculata, Boerhavia diffusa, Azhadirachta indica,Aristolochia indica, Aegle marmelos, Cyperus rotundus, Hemedesmusindicus, Trichosanthes dioica, Santalum alba, Terminalia arjuna,Woodfordia fruiticosa, Glycerrhiza glabra, Mucuna pruriens, Myrica nagi,Plumbago rosea, Inula racemosa, Zingiber officinalis, Piper longum andPiper nigrum in the range of 1 to 4 wt %.

Further, the amount of gum acacia may be any amount suitable to performthe activity of an excipient. In an embodiment, the formulation mayinclude gum acacia in the range of 0 to 50 mg per 500 mg of theformulation, preferably 10 wt %.

However, it is apparent that slight variations in the amount of theingredients may be performed without otherwise deterring from theintended function of the herbo-mineral formulation.

The herbo-mineral formulation disclosed herein may be formulated invarious dosage forms such that it is suitable for oral administration.The herbo-mineral formulation may be in the form of tablets, pellets,lozenges, granules, capsules, solutions, emulsions, suspensions, or anyother form suitable for use. In an embodiment, the herbo-mineralformulation is formulated in the form of tablets, preferably 500 mgtablets. For example: Table 1A depicts the quantities of each ingredientin a 500 mg tablet.

Further disclosed herein, is a tablet for treating/preventing/managingdiabetes and associated complications. In an embodiment, the tablet is a500 mg tablet having herb element, mineral element and an excipient asdepicted in Table 1A.

TABLE 1A Each 500 mg tablet includes: QUANTITY Conc. NO SANSKRIT NAMESCIENTIFIC NAME (mg) (wt %) 1 Ekanayaka dry root Salacia chinensis 30 62 Ashvagandha dry root Withania somnifera 10 2 3 Hareetakee dry fruitTerminalia chebula 10 2 4 Vibhitaki dry fruit Terminalia bellerica 10 25 Meshashrngi dry leaves Gymnema sylvestre 30 6 6 Amalaki dry fruitEmblica officinalis 20 4 7 Kiratatikta dry plant Andrographis paniculata10 2 8 Punarnava dried root Boerhavia diffusa 10 2 9 Nimba dry barkAzhadirachta indica 10 2 10 Ishvari dry root Aristolochia indica 10 2 11Bilva dry root Aegle marmelos 10 2 12 Mustaka dry root Cyperus rotundus10 2 13 Sariva dry root Hemedesmus indicus 10 2 14 Patola dry plantTrichosanthes dioica 10 2 15 Chandana dry heartwood Santalum alba 10 216 Arjuna dry bark Terminalia arjuna 10 2 17 Dhataki dry flowerWoodfordia fruiticosa 10 2 18 Yashtimadhu dry root Glycerrhiza glabra 102 19 Kapikacchu dry seeds Mucuna pruriens 10 2 20 Katphala dry barkMyrica nagi 10 2 21 Jambu dry seeds Eugenia jambolana 30 6 22 ShuddhaChitraka dryroot Plumbago rosea 10 2 23 Haridra dry rhizome Curcumalonga 25 5 24 Guduchi dry stem Tinospora cordifolia 25 5 25 Pushkaramuladry root Inula racemosa 10 2 26 Shunthi dry rhizome Zingiber officinalis10 2 27 Pippali dry fruit Piper longum 10 2 28 Maricha dry fruit Pipernigrum 10 2 29 Abhraka Bhasma Incinerated mica 05 1 30 Vanga BhasmaIncinerated tin 05 1 31 Yashada Bhasma Incinerated Zinc 2.5 0.5 32Pravala Bhasma Incinerated coral 2.5 0.5 33 Loha Bhasma Incinerated iron05 1 34 Swarna MakshikaBhasma Incinerated copper pyrite 05 1 35Shilajatu Asphaltum 20 4 36 Guggulu oleo gum resin Commiphora mukul 25 537 Excipient Gum acacia 50 10

Method

Disclosed herein are embodiments of a method of preparing theherbo-mineral formulation. In an embodiment, the method includes,levigating bhasmas, Guggulu and shilajit in a grinder;

adding finely powdered herbs into the grinder; and

adding grinding decoction while continuing grinding to obtain a groundmass.

The bhasmas include atleast one of Abhraka Bhasma, Vanga Bhasma, Yashadabhasma, Pravala Bhasma, Loha Bhasma and Swarna Makshika Bhasma. Themixture of bhasmas, Guggulu and Shilajit may be in semi-solid form. Inan embodiment, the levigation may be performed for a duration of around3 hours.

Further, the finely powdered herbs include finely powdered dried root ofSalacia chinensis, Withania somnifera, Boerhavia diffusa, Aristolochiaindica, Aegle marmelos, Cyperus rotundus, Hemedesmus indicus,Glycerrhiza glabra, Inula racemosa and Plumbago rosea; dried fruits ofTerminalia chebula, Terminalia bellerica, Emblica officinalis, Piperlongum and Piper nigrum; dried bark of Azhadirachta indica, Myrica nagiand Terminalia arjuna; dried plant of Andrographis paniculata andTrichosanthes dioica; dried leaves of Gymnema sylvestre; dried heartwoodof Santalum alba; dried flowers of Woodfordia fruiticosa; dried seeds ofMucuna pruriens and Eugenia jambolana; dried rhizome of Curcuma longaand Zingiber officinalis; and dried stem of Tinospora cordifolia. In anembodiment, finely powdered herbs may be obtained by powdering andsieving the herb components at 80 mesh.

The grinding decoction is a decoction of the following grinding herbs:Salacia chinensis, Cedrus deodara, Tribulus terrestris, Acacia catechu,Andrographis paniculata, Pterocarpus marsupium, Ocimium sanctum,Adhatoda vasica, Aegle marmelos, Carum carvi, Trigonella foenum graecum,Momordia charantia and Araca catechu. The decoction may be obtained byany method of decocting generally known in the field. In an embodiment,the method of preparation of grinding decoction further includes,soaking the grinding herbs i.e. powdered dry root of Salacia chinensis,dry heartwood of Cedrus deodara, dry fruit of Tribulus terrestris, dryheartwood of Acacia catechu, dry plant of Andrographis paniculata, dryheartwood of Pterocarpus marsupium, dry leaves of Ocimium sanctum, dryleaves of Adhatoda vasica, dry leaves of Aegle marmelos, dry fruits ofCarum carvi, dry seeds of Trigonella foenum graecum, fresh fruit ofMomordia charantia and dry seed of Araca catechu; and concentrating.

In another embodiment, soaking may be performed by soaking the grindingherbs in 16 parts of water overnight. In a further embodiment,concentrating may be performed by boiling at high temperature,preferably about 80 to 85 degree Celsius, until ⅛th of the liquidremains. Concentration may be confirmed with the help of Brix meter.

Further, once the grinding decoction is added, grinding is continued. Inan embodiment, grinding is continued for about 72 hours, preferably at120 rpm, to obtain a ground mass. In an embodiment, the method ofpreparation may further include adding excipient to the ground mass,wherein gum acacia may be added to the ground mass by dissolving in thegrinding decoction while continuing grinding for 3 hours to obtain asemisolid mass. The method of preparation may further include drying at50 degree Celsius, preferably in a hot air oven, wet granulating,punching to obtain 500 mg tablets. FIG. 2 depicts a flowchart for thepreparation of fortified tablets. Table 1B depicts the Herb ingredientsrequired for grinding (grinding herbs) in one of the preferredembodiments.

TABLE 1B List of Grinding herbs Decoction of following herbs: 1Ekanayaka dry root Salacia chinensis 1 part 2 Devadaru dry heartwoodCedrus deodara 1 part 3 Gokshura dry fruit Tribulus terrestris 1 part 4Khadira dry heartwood Acacia catechu 1 part 5 Kiratatikta dry plantAndrographis 1 part paniculata 6 Asana dry heartwood Pterocarpus 1 partmarsupium 7 Tulasi dry leaves Ocimium sanctum 1 part 8 Vasa dry leavesAdhatoda vasica 1 part 9 Bilva dry leaves Aegle marmelos 1 part 10Krshna Jeeraka dry fruits Carum carvi 1 part 11 Methika dry seedsTrigonella foenum 1 part graecum 12 Karavellaka fresh fruit Momordia 1part charantia 13 Puga dry seed Araca catechu 1 part 14 Jala Water 208parts Avashesha (Reduced to) ⅛ part of water

The bhasmas that are used in the various embodiments of the disclosedherbo-mineral formulation may be prepared by methods that are generallyknown in the field. Bhasmas may be prepared by selecting genuinestandard minerals as starting material such as Swarnamakshika, Mica,Iron, tin, zinc etc; drying in a hot air oven; purifying the mineral bytriturating, quenching, boiling etc; triturating with herbal decoction;preparing into discs; drying of discs; preparing sharavasam puta,subjecting Sharavasam puta to Gaja puta, and powdering of discs oncecooled. In an embodiment, the method is repeated 30 times till bhasma isobtained.

The starting materials used in the preparation of bhasmas may includestandard minerals generally used in the field. In an embodiment, thepreparation of Swarna Makshika Bhasma includes swarna makshika as thestarting material. FIG. 1(a) depicts a flowchart for the preparation ofSwarna Makshika Bhasma using swarna makshika as the starting material.In an embodiment, the preparation of Abhraka Bhasma includes Mica as thestarting material. FIG. 1 (b) depicts a flowchart for the preparation ofAbhraka Bhasma using Mica as the starting material. In an embodiment,the preparation of Loha Bhasma includes steel iron as the startingmaterial. FIG. 1(c) depicts a flowchart for the preparation of LohaBhasma using steel iron as the starting material. In another embodiment,the preparation of Vanga Bhasma includes Tin and lead as the startingmaterial. FIG. 1(d) depicts a flowchart for the preparation of VangaBhasma using alloys of Tin and lead as the starting material. In anembodiment, the preparation of Pravala Bhasma includes Coral as thestarting material. FIG. 1(e) depicts a flowchart for the preparation ofPravala Bhasma using Coral as the starting material. In an embodiment,the preparation of Yashada Bhasma includes Zinc as the startingmaterial. FIG. 1(f) depicts a flowchart for the preparation of YashadaBhasma using Zinc as the starting material.

The purification, or shodhana, of the mineral may be performed bygenerally known methods in the field. In an embodiment, the purificationmay be by mixing the mineral, such as swarna makshika, with rocksalt andlemon juice and heating strongly till partially oxidized into reddishpowder which may further be used in the preparation of Swarna makshikaBhasma. In another embodiment, the purification may be by quenching amineral such as micain Cow's milk, wherein it is further used in thepreparation of Abhraka Bhasma.

In yet another embodiment, the purification may be by quenching amineral such as steel iron in Triphala decoction, which is further usedin the preparation of Loha Bhasma. In yet another embodiment, thepurification may be by melting and pouring the mineral for example Tinor Zinc in lime water, preferably seven times, which is further used inthe preparation of Vanga Bhasma or Yashada Bhasma, respectively.

Further, in an embodiment, the process of purification may includeboiling mineral such as Coralin an alkaline solution of Barilla, whichis further used in the preparation of Pravala Bhasma.

The herbal decoction/juices used for triturating may be any herbaldecoction/juice that is generally used for triturating in thepreparation of bhasmas. For example, the herbal decoction/juice mayinclude triphala, lemon juice, Gomutra (cow's urine) etc. The followingare herbal decoction/juices that may be used in trituration whilepreparing various bhasmas:

Table A illustrates the ingredients of Herbal decoction used fortrituration while preparing Abhraka Bhasma.

TABLE A Decoction of following herbs: 1. Amalaki dried fruit Emblicaofficinalis 1 part 2. Hareetaki dried fruit Terminalia chebula 1 part 3.Vibheetaki dried fruit Terminalia bellerica 1 part 4. Musta driedrhizome Cyperus rotundus 1 part 5. Vata dried root bark Ficusbengalensis 1 part 6. Haridra dried rhizome Curcuma longa 1 part 7. JalaWater 96 parts Avashesha (Reduced to) ⅛ part of liquid

Table B illustrates the ingredients of Herbal juice used for triturationwhile preparing Abhraka Bhasma.

TABLE B Juice of following herbs: 1. Kasamarda fresh leaves Cassiaoccidentalis 1 part 2. Tambula fresh leaves Piper betle 1 part 3. Vasafresh leaves Adhatoda vasica 1 part 4. Amalaki fresh fruit Emblicaofficinalis 1 part 5. Matsyakshi fresh plant Alternathera sessilis 1part 6. Tanduleeyaka fresh plant Amaranthus spinosus 1 part 7. Erandafresh leaves Ricinus communis 1 part 8. Arka fresh leaves Calotropisprecera 1 part

Table C illustrates the ingredients of Herbal decoction used fortrituration while preparing Vanga Bhasma.

TABLE C Decoction of following herbs: 1. Amalaki Embhca officinalis 1part 2. Hareetaki Terminalia chebula 1 part 3. Vibheetaki Terminaliabellerica 1 part 4. Haridra dried rhizome Curcuma longa 1 part 5. JalaWater 64 parts Avashesha (Reduced to) 1/8 part of liquid

Table D illustrates the ingredients of Herbal juice used for triturationwhile preparing Vanga Bhasma.

TABLE D Juice of following herbs: 1. Kumari fresh leaves Aloe vera 1part

Table E illustrates the ingredients of Herbal juice used for triturationwhile preparing Yashada Bhasma

TABLE E Juice of following herbs: 1. Kumari fresh leaves Aloe vera 1part 2. Nimbu fresh fruit Citrus limon Linn. 1 part

Table F illustrates the ingredients of Herbal decoction used for thetrituration to prepare Loha Bhasma.

TABLE F Decoction of following herbs: 1. Amalaki Emblica officinalis 1part 2. Hareetaki Terminalia chebula 1 part 3. Vibheetaki Terminaliabellerica 1 part 4. Varuna Crataeva nurvala 1 part 5. PunarnavaBoerhavia diffua 1 part 6. Kanchanara Bauhinia variegata 1 part 7.Gomutra Cow urine 48 parts 8. Jala Water 48 parts Avashesha (Reduced to)1/8 part of liquid

Table G illustrates the ingredients of Herbal juice used for triturationwhile preparing Swarna Makshika Bhasma.

TABLE G Juice of following herbs: 1. Nimbu fresh fruit Citrus limonLinn. 1 part

Treatment

Disclosed herein are embodiments of the method oftreating/preventing/managing Diabetes and Diabetes associatedcomplications. The embodiments disclosed herein are instrumental inreducing elevated fasting and post prandial blood sugar levels andelevated HbA1C levels.

In an embodiment, the method includes administering to a patient acomposition as described in any of the embodiments disclosed herein. Inan embodiment, the patient may be any individual in need of suchtreatment including ones having/expected or suspected of havingDiabetes. Further, the patient may also be any individualhaving/suspected of having complications associated with Diabetes suchas hyperglycemia, hyperlipidemia, etc. The patient may also include anyindividual showing diabetes symptoms such as individuals having ≥5.7 wt% of HdA1C levels, ≥100 mg/dl of FBS, ≥140 mg/dl of OGTT etc.

In a preferred embodiment, the method includes administering to apatient a composition having herb element, mineral element and suitableexcipient, wherein the herb element includes Salacia chinensis (4 to 8wt %), Gymnema sylvestre (4 to 8 wt %), Emblica officinalis (2 to 6 wt%), Eugenia jambolana (4 to 8 wt %), Curcuma longa (3 to 7 wt %),Commiphora mukul (Guggulu) (3 to 7 wt %), Tinospora cordifolia (3 to 7wt %) and atleast one of herb selected from Withania somnifera,Terminalia chebula, Terminalia bellerica, Andrographis paniculata,Boerhavia diffusa, Azhadirachta indica, Aristolochia indica, Aeglemarmelos, Cyperus rotundus, Hemedesmus indicus, Trichosanthes dioica,Santalum alba, Terminalia arjuna, Woodfordia fruiticosa, Glycerrhizaglabra, Mucuna pruriens, Myrica nagi, Plumbago rosea, Inula racemosa,Zingiber officinalis, Piper longum and Piper nigrum; and the mineralelement includes Shilajit (2 to 6 wt %) and atleast one of bhasmaselected from Abhraka Bhasma (≤2 wt %), Vanga Bhasma (≤1 wt %), YashadaBhasma (≤1 wt %), Pravala Bhasma (≤2 wt %), Loha Bhasma (≤2 wt %) andSwarna Makshika Bhasma (≤2 wt %).

In an embodiment, the disclosed formulation may also be used to preventthe complications of diabetes like retinopathy, neuropathy, nephropathyand vascular diseases.

In a further embodiment, the disclosed formulation may be used to reduceenhanced levels of lipid/cholesterol levels, tissue phosphatases andtissue transaminases in the diabetic tissues. Furthermore, in anembodiment, the disclosed formulation may be instrumental in reversingthe glycogen and protein depletion that is generally observed in tissuesof diabetic subjects.

The disclosed method of treatment may be used as a primary line oftreatment or as an adjunct to other diabetic treatment. In anembodiment, the disclosed formulation may be used to stimulateregeneration of β cells of islets of pancreas. In an embodiment, thedisclosed formulation may be useful as a hypoglycemic, hypolipidemic,cytoprotective and immunomodulatory agent. In an embodiment, thedisclosed formulation may be used to improve the quality of life ofDiabetic patients. Further, in an embodiment, the disclosed formulationmay be instrumental reducing FBS, PPBS, HbA1C level and also improvingclinical symptoms

One of the embodiments relating to the formulations disclosed herein(also referred as Test product) was further tested for efficacy at 3levels Experimental study, Clinical study and Quality of Life (QOL)assessment, as described hereunder by way of examples. The embodiment isfurther described by reference to the following examples by way ofillustration only, and should not be construed to limit the scope of theclaims provided herewith. It will be apparent to those skilled in theart that many modifications, both to materials and methods, may bepracticed without departing from the scope of the claims.

Example 1: Experimental Study

The aim of this study was to analyze the action of test product on bloodglucose, lipids, tissue proteins, pancreatic amylase and islet cells ofpancreas in alloxan induced diabetic rats.

Experiment Details:

Animals: Albino rats of Wistar strain, of either sex, fed with standardrat pellets and water ad libitum.

Experimental diabetes: Diabetes was induced by a single intra-peritonealinjection of 5% alloxan monohydrate dissolved in 0.9% saline, at a doseof 200 mg/kg body weight, after a 16 hour fast.

Test drug therapy: The tablets were powdered, weighed and mixed withwater to form a uniform suspension, which was administered orally everymorning using a gastric tube.

Dose: 1 ml (30 mg/cc)

Results:

FIG. 3 illustrates the results of the Oral glucose tolerance test innormal and diabetic rats after Test product treatment. The treatednormal rats showed hypoglycemic effects, while the diabetic animalsshowed significant reduction in blood glucose levels.

FIG. 4 illustrates the effect of Test product on protein depletion indiabetic rats. Protein depletion in vital organs was found reduced.

FIG. 5 illustrates the effect of Test product on tissue glycogendepletion in diabetic rats. Glycogen depletion was found reduced by Testproduct therapy.

FIG. 6 illustrates the effect of Test product on tissue lipids of normaland diabetic rats. The enhanced lipid levels in the diabetic state werefound to be significantly reduced after treatment.

FIG. 7 illustrates the effect of Test product on Cholesterol of normaland diabetic rats. The enhanced cholesterol levels in the diabetic statewere found to be markedly reduced after treatment.

FIG. 8 illustrates the effect of Test product on tissue phosphatases.The enhanced levels of tissue phosphatases (acid and alkalinephosphatases) and tissue transaminases (alanine and aspartatetransaminases) in the diabetic tissues showed significant reductionafter treatment.

FIG. 9 illustrates the effect of Test product on tissue transaminase indiabetic rats. Pancreatic amylase activities were below normal indiabetic animals. Administration of Test product could elevate theenzyme levels, but not to normal levels.

FIG. 10(a), FIG. 10(b) and FIG. 10(c) illustrates the Histologicalstudies made in pancreas of diabetic rats. The study showed islet cellde-granulation and destruction of B cells. Regeneration of B-cells andincreased islet cell mass was noted in the pancreas of diabetic ratsafter Test product administration. FIG. 10(a) is a photomicrograph ofPanreatic islet from normal rats (200×); FIG. 10(b) is a photomicrographof Panreatic islet from alloxan induced diabetic rats showingdegranulation and necrotic B cells (300×); and FIG. 10(c) is aphotomicrograph of pancreatic islet from diabetic rats treated withDisclosed Formulation which is showing marked regeneration.

Example 2: Clinical Study

The aim of this clinical study was to evaluate the clinical efficacy andsafety (long-term and short-term) of Test product as monotherapy and asan adjunct with other oral hypoglycemic drugs in management of NIDDM.This study helps evaluate the action of Test product on clinical andbiochemical features of diabetic patients.

Study Design: This was a prospective, open, non-randomized, phase IIIclinical trial conducted at the Out Patient Department of MuniyalAyurvedic Hospital and Research Centre, Manipal, India.

Materials and Methods

Inclusion Criteria: A total of 340 patients of either sex, between 30-60years of age in whom the diagnosis of NIDDM was confirmed, and who werewilling to give informed consent were included in the study. The WHOdiagnosis criteria (1980) was considered for diagnosis of NIDDM (Fornewly diagnosed patients: FBSL >120 mg % and after 2 hours of consuming75 grams of glucose: >180 mg %).

Exclusion Criteria: Insulin-dependent diabetes mellitus patients andNIDDM patients with acute complications of diabetes were excluded fromthe trial. Pregnant and lactating women, patients with concomitantsevere illness necessitating other medications, patients with severehypertension, history of severe unstable angina, myocardial infarction,CVAs, renal failure, and those patients, who were not willing to giveinformed consent were also excluded from the study.

Study Procedure:

Dose and Duration: Patients were advised to consume 2 tablets of Testproduct, thrice daily, for 3 months i.e. 2 tablets of Test product afterbreakfast followed by another 2 tablets after lunch, and 2 tablets afterdinner.

In all the patients, blood sugar level was assessed at the time ofenrolment and thereafter every month, for 3 months. All the patients hadto undergo biochemical laboratory investigations. The improvement in theNIDDM symptoms was assessed using a predefined symptom scores. Allpatients were investigated for urine (routine and microscopic),hemogram, total leucocyte count, differential leucocyte count, serumcreatinine, blood urea, serum albumin, serum globulin and lipid profile.Scale from 0 to 3 (0=absent, 1=mild, 2=moderate and 3=severe).

Primary and Secondary Endpoints: The predefined primary efficacy endpoints were PPBSL control and reduction in the dose of other oralhypoglycemic drugs. The PPBSL control was graded as: excellent: up to130 mg %, good: upto 150 mg %, fair: upto 180 mg %, poor: up to 250 mg %and treatment failure: >250 mg %. The predefined secondary safetyendpoints were reduced incidence of adverse reactions and overallcompliance to the drug therapy.

Follow-up and Assessment: All patients were followed up for 3 months(during the treatment period) and at each follow-up visit, the patient'sresponse to the study drug was recorded in a structured CRF. Thesubjective symptomatic relief and changes in the symptom score scale foreach symptom were recorded during each follow-up visit.

Adverse Events: All adverse events reported or observed by patients wererecorded with information about the severity, date of onset, durationand action taken regarding the study drug. Relation of adverse events tostudy medication was predefined as “Unrelated” (a reaction that does notfollow a reasonable temporal sequence from the time of administration ofthe drug), “Possible” (follows a known response pattern to the suspecteddrug, but could have been produced by the patient's clinical state orother modes of therapy administered to the patient), and “Probable”(follows a known response pattern to the suspected drug that could notbe reasonably explained by the known characteristics of the patient'sclinical state).

Patients were allowed to voluntarily withdraw from the study, if theyhad experienced serious discomfort during the study or sustained seriousclinical events requiring specific treatment. For patients withdrawingfrom the study, efforts were made to ascertain the reason for dropout.Non-compliance (defined as failure to take less than 80% of themedication) was not regarded as treatment failure, and reasons fornon-compliance were noted.

Statistical Analysis: Statistical analysis was done according tointention-to-treat principles. The changes in various parameters frombaseline values and the values after 1st, 2nd and 3rd month wereanalyzed by “Paired “t” Test”. The minimum level of significance wasfixed at 95% confidence limit and a 2-sided p value of <0.05 wasconsidered as significant.

Results:

Assessment variables that include clinical features of diabetes mellituslike polyuria, polydipsia, polyphagia, burning sensation and lassitudewere given comparative scoring and the mean scores before and after theadministration of Test product supplement t were compared. Table 2depicts the results of the action of Test product on various features ofDiabetes mellitus. From the table it is clear that there is aconsiderable reduction in the severity of clinical features of Diabetesmellitus which is found to be statistically highly significant(P<0.001).

TABLE 2 Results of action on clinical features Mean ± S.D AssessmentVariables BT AT t value P value Polyurea 2.3 ± 0.66 0.30 ± 0.47 13.78 P< 0.001 Polydypsia 2.1 ± 0.72 0.35 ± 0.48 14.23 P < 0.001 Polyphagia 1.4± 0.75 0.25 ± 0.44 8.76 P < 0.001 Burning 1.90 ± 0.97  0.55 ± 0.75 9.0 P< 0.001 Sensation Lassitude 1.75 ± 0.55  0.45 ± 0.51 12.37 P < 0.001

Table 3 depicts the results of the action of Test product Tablets onBlood Sugar. A significant reduction was observed in both FBS and PPBS(23.75% and 30.95% respectively). Results were also statistically highlysignificant at P<0.001.

TABLE 3 Results of action on Blood sugar Assessment Mean ± S.D %Variables BT AT t value P value reduction Fasting blood 126.3 ± 0.52mg/dl  96.3 ± 0.56 mg/dl 12.26 P < 0.001 23.75 sugar Post prandial 290.5± 0.23 mg/dl 200.6 ± 0.64 mg/dl 11.35 P < 0.001 30.95 blood sugar

Example 3: Quality of Life Study

Study design: Prospective observational study design

Sources of Data:

Primary Data: Patient Case Records and interviewing the patients.

Secondary Data: Internet websites, Ayurvedic text books, Journals.

Inclusion Criteria:

-   -   All type II diabetes mellitus patients    -   Age 18-75 years    -   Patients with Diabetes Mellitus taking only Test Product tablets    -   Patients who agreed to sign ICF    -   Patients in whom the treatment pattern will not change till 3        months

Exclusion Criteria:

-   -   Type I diabetes patients.    -   Pregnant ladies.    -   Lactating women.    -   Chronically ill patients.    -   Patient who are on life style modification or on diet therapy        (pre diabetic patient).    -   Patient who refused to be part of the study.

Study site: This study was conducted in group of patients receiving TestProduct tablets for the treatment of type II diabetes mellitus in andaround Udupi and Manipal region, Karnataka.

Study Duration: Total duration of the study was 6 months.

Research Instruments:

-   -   Patient Data Collection Form    -   DMSAT Questionnaire    -   QOL Questionnaire    -   Kuppuswamy socio-economic scale

Results:

Demographics:

-   -   Total no. of patients participated: 53    -   Total no. of patients completed the study: 51    -   Total no. of male patients: 41    -   Total no. of female patients: 10

Table 4 illustrates age and sex wise distribution of patients.

TABLE 4 age and sex wise distribution of patients No. of patients ineach group Male Female Total Group 1 (36-45 years) 7 1 8 Group 2 (36-45years) 9 6 15 Group 3 (36-45 years) 19 2 21 Group 4 (36-45 years) 6 1 7Total 41 10 51

Clinical Efficacy:

Efficacy was calculated by measuring the fasting blood glucose level andHbA1c at four intervals that is on Day1, Day15, Day 30 and Day90.

Results:

Overall Patient Clinical Data:

Table 5 illustrating FBS data of overall patients shows an averagereduction of 34.49% at the end of 90 days.

TABLE 5 FBS data Day Mean ± SD (mg/dl) % Reduction 1 188.24 ± 41.3934.49% 15 167.63 ± 35.24 30 149.78 ± 33.58 90 123.31 ± 25.97

Table 6 illustrating HbA1c data of overall patients shows an averagereduction of 28.27% in 90 days.

TABLE 6 HbA1c data Day Mean ± SD (mg/dl) % Reduction 1 8.88 ± 1.6728.27% 90 6.37 ± 0.98

Table 7 depicts that a marked improvement was observed in all theparameters of patient satisfaction indicating the high acceptability ofthe product.

TABLE 7 Results for parameters of patient satisfaction Scores ParametersDay 15 Day 30 Day 90 % Improvement Well being 0.32 0.46 0.62 48.39%Glucose control 0.33 0.46 0.61 45.90% Life style 0.30 0.41 0.53 43.40%Convenience 0.32 0.42 0.56 42.86% Overall 0.32 0.44 0.58 44.83%

Quality of Life Study Results: Effect of Test Drug on PCS:

Table 8 depicts that a 30.01% improvement was seen in Physical ComponentScore observed after 90 days of treatment with Test drug.

TABLE 8 Physical Component Score Day Mean ± SD (mg/dl) % Reduction 1534.58 30.01% 30 41.3 90 49.41

Effect on Test Drug on MCS:

Table 9 depicts that a 52.52% improvement was seen in Mental ComponentScore after 90 days of treatment with Test product.

TABLE 9 Mental Component Score Day Mean ± SD (mg/dl) % Reduction 1525.63 52.52% 30 39.67 90 53.98

Example 4: Study of Efficacy of Test Drug in the Management of InsulinDependent Diabetes Mellitus Introduction:

Type I diabetes is also known as insulin-dependent diabetes mellitus(IDDM) caused mainly due to less production of insulin. Type IIdiabetes, on the other hand, also known as non-insulin-dependentdiabetes mellitus (NIDDM) is caused mainly due to the inability of bodycells to respond to the insulin produced.

Test drug has shown highly encouraging results in the management of TypeII (NIDDM) diabetes mellitus. In experimental study test drug was foundto regenerate β cells of islets of pancreas that secrete insulin. Henceit was planned to try the test drug among the patients of IDDM withregular careful follow up.

Materials and Methods:

Adult patients (20 years to 60 years) under insulin therapy wereselected for the study. Juvenile diabetes mellitus and patients withcomplications are excluded from the study.

Study was obtained Institutional Ethical Clearance. Patients wereenrolled after taking written consents. All the clinical features,detailed history and investigative findings are recorded in thespecially designed clinical proforma.

Dose:

Initial dose was two tablets twice daily after food. When normoglycemicstage is attained with Fasting Blood Sugar Less than 110 mg/dl and PostPrandial Blood Sugar less than 140 mg/dl and HBA1C within 6.5, Insulindose was gradually tapered and dose of test drug was increased to twotablets thrice daily.

Duration: Study was carried out for three months. It was a singleblinded clinical study with pre and post-test design.

Total number of patients studied: 18

Maximum numbers of patients were of the age group between 41 and 50years. Majority of the patients were male. Table 10 illustrates the ageand sex wise distribution of the patients.

TABLE 10 Distribution of the patients-age and sex. Age Male Female Total21-30 years 01 00 01 31-40 years 02 01 03 41 to 50 years 06 04 10 51 to60 years 02 02 04 Grand total 11 07 18

Majority of the patients were on Insulin since less than 5 years. Table11 illustrates distribution according to the chronicity of the disease.

TABLE 11 Distribution of the patients-chronicity of the disease YearsNo. of patients Less than 5 years 11 6-10 years 04 10-15 years 02 15-20years 01 Above 20 years 00

All the patients were under Human Mixtard Insulin (70:30). Table 12illustrates distribution of patients according to Insulin dose. Maximumnumbers of patients were taking Insulin between 21 and 30 units.

TABLE 12 Distribution of patients-Insulin unit/day. Units per day No. ofpatients Less than 10 02 11-20 02 21-30 10 31-40 03 Above 40 units 1

Results:

Table 13 illustrates the effect of Test drug on Fasting blood sugar.

TABLE 13 FBS data Day Mean ± SD (mg/dl) % Reduction 1 179.24 ± 41.3936.78% 15 162.63 ± 35.24 30 143.78 ± 33.58 90 113.31 ± 25.97

Table 14 illustrates the effect of Test drug on Post Prandial bloodsugar.

TABLE 14 PPBS data Day Mean ± SD (mg/dl) % Reduction 1 208.24 ± 41.3935.98% 15 187.63 ± 35.24 30 169.78 ± 33.58 90 133.31 ± 25.97

Table 15 illustrates the effect of Test drug on HbA1c level.

TABLE 15 HbA1c data Day Mean ± SD (mg/dl) % Reduction 1 8.95 ± 1.6730.61% 90 6.21 ± 0.98

Table 16 illustrates the effect of test drug on Insulin dose.

TABLE 16 Reduction in Insulin dose Before treatment After treatment %Reduction 27 ± 1.12 18 ± 1.67 33

Observation:

The study is highly encouraging as it was observed that the need ofinsulin among the patients after the treatment is reduced. All thepatients under test were on both oral hypoglycemic drugs and Insulin.Two patients taking Insulin less than 10 units per day could completelystop insulin and remain on oral hypoglycemic agents. The findingssuggest that Insulin secretion is improved in the patients. Experimentalstudy has also shown that test drug helps to regenerate degranulated βcells in islets of pancreas.

Herbs like Punarnava (Boerhavia diffusa), Kumari (Aloe vera) present inthe formulation are known to have insulino-mimetic activity. Ingredientslike Aloe vera and Mucuna pruriens increase insulin secretion.Ingredients like Salacia act as anti-oxidants, improves body'ssensitivity to insulin and supress glucose absorption. Phytoconstituents like alkaloids inhibit alpha-glucosidase and decreaseglucose transport through the intestinal epithelium. Imidazolinecompounds stimulate insulin secretion in a glucose-dependent manner.Polysaccharides increase the level of serum insulin, reduce the bloodglucose level and enhance tolerance to glucose. Flavonoids suppress theglucose level, reduce plasma cholesterol and triglycerides significantlyand increase hepatic glucokinase activity probably by enhancing theinsulin release from pancreatic islets.

CONCLUSION

Even though the sample size is small initial observations clearlyindicate that test drug can be effectively used among the diabetespatients who are already on insulin therapy. Dose of insulin was reducedand glycemic control was improved.

The treatment regimen employing the embodiments of the Disclosedformulation and the dosages may vary depending on the patient. Theembodiments disclosed herein were evaluated as per international OECDguidelines (423, 407, 408 and 452) and was found to be safe andnon-toxic. The LD50 value of test drug was found to be greater than 5000mg/kg body weight and classified as Category-5 or unclassified based onGlobally Harmonised Classification System (GHS) for Chemical Substancesand Mixtures.

The foregoing description of the specific embodiments will so fullyreveal the general nature of the embodiments herein that others can, byapplying current knowledge, readily modify and/or adapt for variousapplications such specific embodiments without departing from thegeneric concept, and, therefore, such adaptations and modificationsshould and are intended to be comprehended within the meaning and rangeof equivalents of the disclosed embodiments. It is to be understood thatthe phraseology or terminology employed herein is for the purpose ofdescription and not of limitation. Therefore, while the embodimentsherein have been described in terms of preferred embodiments, thoseskilled in the art will recognize that the embodiments herein can bepracticed with modification within the spirit and scope of theembodiments as described herein.

We claim:
 1. A formulation for treatment and management of Diabetes andrelated complications comprising: a herb element comprising of Salaciachinensis, Gymnema sylvestre, Emblica officinalis, Eugenia jambolana,Curcuma longa, Commiphora mukul (Guggulu) and Tinospora cordifolia ortheir extracts thereof; and a mineral element comprising of shilajit andbhasma.
 2. The formulation as claimed in claim 1 wherein said herbelement further comprises atleast one herb selected from a groupconsisting of Withania somnifera, Terminalia chebula, Terminaliabellerica, Andrographis paniculata, Boerhavia diffusa, Azhadirachtaindica, Aristolochia indica, Aegle marmelos, Cyperus rotundus,Hemedesmus indicus, Trichosanthes dioica, Santalum alba, Terminaliaarjuna, Woodfordia fruiticosa, Glycerrhiza glabra, Mucuna pruriens,Myrica nagi, Plumbago rosea, Inula racemosa, Zingiber officinalis, Piperlongum and Piper nigrumor their extracts thereof.
 3. The formulation asclaimed in claim 1, wherein said mineral element comprises of atleastone bhasma selected from a group consisting of Abhraka Bhasma, VangaBhasma, Yashada Bhasma, Pravala Bhasma, Loha Bhasma and Swarna MakshikaBhasma.
 4. The formulation as claimed in claim 1, wherein Salaciachinensis is present in an amount ranging from 4 to 8 wt %, Gymnemasylvestre is present in an amount ranging from 4 to 8 wt %, Emblicaofficinalis is present in an amount ranging from 2 to 6 wt %, Eugeniajambolana is present in an amount ranging from 4 to 8 wt %, Curcumalonga is present in an amount ranging from 3 to 7 wt %, Commiphora mukul(Guggulu) is present in an amount ranging from 3 to 7 wt % and Tinosporacordifolia is present in an amount ranging from 3 to 7 wt %.
 5. Theformulation as claimed in claim 1, wherein shilajit is present in anamount ranging from 2 to 6 wt %.
 6. The formulation as claimed in claim3, wherein concentration of Abhraka Bhasma is about 2 wt %,concentration of Vanga Bhasmais about 1 wt %, concentration of YashadaBhasma is about 1 wt %, concentration of Pravala Bhasma is about 2 wt %,concentration of Loha Bhasma is about 2 wt % and concentration of SwarnaMakshika Bhasma is about 2 wt %.
 7. The formulation as claimed in claim1, further comprising a suitable excipient, preferably gum acacia. 8.The formulation as claimed in claim 1, further comprising one or moreadditives selected from the group consisting of a flavor, a colorant, apreservative, and a pH adjuster.
 9. The formulation as claimed in claim1, wherein said formulation is administered in a form selected from agroup consisting of powder, emulsion, tablets, capsules, troches andpills
 10. The formulation as claimed in claim 1, wherein saidformulation is prepared in the form of a tablet.
 11. The formulation asclaimed in claim 10, wherein said tablet is in the form of 500 mgtablets.
 12. Use of formulation as claimed in claim 1 in the preparationof a medicament for treatment of a condition selected from a groupconsisting of diabetes, hyperglycemia, low glucose tolerance,hyperinsulinemia and related complications.
 13. A process for thepreparation of formulation as claimed in claim 1, comprising: levigatingbhasmas, Guggulu and shilajit; adding finely powdered herbs; and addinggrinding decoction while continuing grinding to obtain a ground mass.14. The process for the preparation of formulation as claimed in claim13, wherein said bhasmas are selected from a group consisting of AbhrakaBhasma, Vanga Bhasma, Yashada Bhasma, Pravala Bhasma, Loha Bhasma andSwarna Makshika Bhasma.
 15. The process for the preparation offormulation as claimed in claim 13, wherein said finely powdered herbscomprises of finely powdered form of atleast one herb selected from agroup consisting of dried root of Salacia chinensis, dried root ofWithania somnifera, dried root of Boerhavia diffusa, dried root ofAristolochia indica, dried root of Aegle marmelos, dried root of Cyperusrotundus, dried root of Hemedesmus indicus, dried root of Glycerrhizaglabra, dried root of Inula racemosa, dried root of Plumbago rosea,dried fruits of Terminalia chebula, dried fruits of Terminaliabellerica, dried fruits of Emblica officinalis, dried fruits of Piperlongum and dried fruits of Piper nigrum, dried bark of Azhadirachtaindica, dried bark of Myrica nagi, dried bark of Terminalia arjuna,dried plant of Andrographis paniculata, dried plant of Trichosanthesdioica, dried leaves of Gymnema sylvestre, dried heartwood of Santalumalba, dried flowers of Woodfordia fruiticosa, dried seeds of Mucunapruriens, dried seeds of Eugenia jambolana, dried rhizome of Curcumalonga, dried rhizome of Zingiber officinalis and dried stem of Tinosporacordifolia.
 16. The process for the preparation of formulation claimedin claim 13, wherein said grinding decoction is a decoction of at leastone herb selected from the group consisting of Salacia chinensis, Cedrusdeodara, Tribulus terrestris, Acacia catechu, Andrographis paniculata,Pterocarpus marsupium, Ocimium sanctum, Adhatoda vasica, Aegle marmelos,Carum carvi, Trigonella foenum graecum, Momordia charantia and Aracacatechu.
 17. A method of treating diabetes and associated complicationscomprising administering a therapeutically effective amount of theformulation claimed in claim
 1. 18. The method of treating Diabetes andassociated complications as claimed in claim 17, wherein saidtherapeutically effective amount is 500 to 1000 mg administered one tothree times a day.
 19. The method as claimed in claim 17 wherein saidformulation is administered along with administration of at least oneother medication prescribed for treatment of Diabetes and associatedcomplications.